By Verne A. Luckow, PhD, JD
Volume 11, Issue 1 (Spring 2012)
The Patient Protection and Affordable Care Act (PPACA), which was passed in 2010, included the Biologics Price Competition and Innovation Act (BPCIA) authorizing the United States Food and Drug Administration (FDA) to establish an abbreviated regulatory approval pathway for complex macromolecules produced in living cells or organisms. The BPCIA implements many new provisions relating to the abbreviated review and approval of follow-on biopharmaceutical products. These include: (1) evaluating the biochemical properties of reference and follow-on macromolecules; (2) establishing procedures for the exchange of information between product sponsors, regulatory agencies, and the federal court system; and (3) establishing periods of regulatory exclusivity which complement patent rights typically awarded to the sponsor of a reference molecule. Important aspects of the BPCIA, particularly issues relating to the exchange of information between product sponsors and the establishment of periods of regulatory exclusivity protecting a novel or follow-on macromolecule are discussed in this article. This is the second in a series of three articles describing key provisions of the Leahy-Smith America Invents Act (AIA) and the BPCIA that affect intellectual property rights of academic and corporate institutions having an interest in the life sciences…
Citation: Luckow VA. Recent Statutes, Regulations, and Court Cases Affecting Intellectual Property Rights of Life Sciences Institutions: Key Provisions of the Leahy-Smith America Invents Act and the Biologics Price Competition and Innovation Act; Part II: Analysis of the BPCIA, the Pre-Approval Patent Resolution Process, Regulatory Exclusivity Periods, and Complementary Rules Affecting Patent Terms. BioProcess J, 2012; 11(1): 11-21. https://dx.doi.org/10.12665/J111.Luckow
Posted online March 12, 2012